BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1861687 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-09991
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PAUSES IN VENTRICULAR PACING OCCURRED OVERNIGHT. THE PACE/SENSE PORTION OF THE DEFIB LEAD WAS PROPHYLACTICALLY REPLACED WITH NEW PACE/SENSE LEAD YESTERDAY. RV CAPTURE MANAGEMENT FEATURE SHOWS GOOD THRESHOLD OF 0.625 VOLTS AT 0.4MS. MANUAL TESTING SHOWED THE SAME RESULTS. THE COMPANY REPRESENTATIVE PERFORMED PROVOCATIVE TESTING; MANIPULATION OF POCKET, MOVING ARMS AND ISOMETRICS BUT NO ISSUES WERE FOUND. THE PHYSICIAN BELIEVES THAT IT COULD BE FAILURE TO CAPTURE DUE TO PATIENTS PROFOUND SLEEP APNEA LEADING TO HYPOXIA. THE PATIENT WILL BE MONITORED OVERNIGHT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB